EP3295885B1 - Corrugated radiofrequency ablation catheter having wall-attaching adjustment wires and apparatus thereof - Google Patents

Corrugated radiofrequency ablation catheter having wall-attaching adjustment wires and apparatus thereof Download PDF

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Publication number
EP3295885B1
EP3295885B1 EP16792177.4A EP16792177A EP3295885B1 EP 3295885 B1 EP3295885 B1 EP 3295885B1 EP 16792177 A EP16792177 A EP 16792177A EP 3295885 B1 EP3295885 B1 EP 3295885B1
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EP
European Patent Office
Prior art keywords
electrode frame
corrugated
wall
radio frequency
wire
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EP16792177.4A
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German (de)
English (en)
French (fr)
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EP3295885A4 (en
EP3295885A1 (en
Inventor
Yonghua DONG
Meijun SHEN
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Shanghai Golden Leaf Med Tec Co Ltd
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Shanghai Golden Leaf Med Tec Co Ltd
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Priority claimed from CN201520605029.2U external-priority patent/CN205019161U/zh
Priority claimed from CN201510492572.0A external-priority patent/CN105078571B/zh
Application filed by Shanghai Golden Leaf Med Tec Co Ltd filed Critical Shanghai Golden Leaf Med Tec Co Ltd
Publication of EP3295885A1 publication Critical patent/EP3295885A1/en
Publication of EP3295885A4 publication Critical patent/EP3295885A4/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00331—Steering mechanisms with preformed bends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/0091—Handpieces of the surgical instrument or device
    • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/0091—Handpieces of the surgical instrument or device
    • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • A61B2018/0094—Types of switches or controllers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1435—Spiral
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1465—Deformable electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • the present invention relates to a corrugated radio frequency ablation catheter having a wall-attaching adjustment wire, also relates to a radio frequency ablation apparatus comprising the radiofrequency ablation catheter, and belongs to the technical field of interventional medical instruments.
  • a radiofrequency ablation catheter is a key device used for human blood vessel intervention and radiofrequency energy release.
  • Radiofrequency electrodes are installed on a frame at the front extremity of the radiofrequency ablation catheter, the frame is used for bearing the radiofrequency electrodes, and the frame expands to be attached to the wall before radiofrequency starts and retracts after radiofrequency ends. Since radiofrequency ablation surgery is conducted through direct human blood vessel intervention, the expanding and retracting size of the frame needs to be matched with the diameters of human blood vessels.
  • the diameters of human blood vessels vary with ablation portions. Besides, the diameters of human blood vessels vary from person to person. For example, the renal artery diameters of different persons range from 2 mm to 12 mm, showing a great difference.
  • the expanding and retracting size of the electrode end of the radiofrequency ablation catheter is generally fixed and can not adapt to different diameters of human blood vessels, thus being small in coverage over human blood vessels with different diameters. Therefore, when radiofrequency ablation surgery is conducted on different patients, radiofrequency ablation catheters of different specifications and models are usually required for ablation. Even so, the problem that radiofrequency electrodes can not be attached to the wall at the same time still exists during certain surgery, and the surgical effect is influenced.
  • Radio frequency ablation catheters can be of various structures based on the shape of electrodes and the shape of an electrode frame, such as a balloon type, a puncture needle type, a spiral type and a lobe structure.
  • the adaptability of all existing radio frequency ablation catheters to blood vessels with different diameters is limited.
  • the primary technical problem to be solved by the present invention is to provide a corrugated radio frequency ablation catheter having a wall-attaching adjustment wire.
  • Another technical problem to be solved by the present invention is to provide a radio frequency ablation apparatus comprising the radio frequency ablation catheter.
  • the front extremity of the wall-attaching adjustment wire run through lumens in the electrode frame and the connecting catheter, returns to the rear extremity of the connecting catheter, and is fixed to the control handle or the control element.
  • the front extremity of the wall-attaching adjustment wire is fixed to the front extremity of the electrode frame after returning to the interior of the electrode frame.
  • the front extremity of the wall-attaching adjustment wire is fixed to the front extremity of the electrode frame or limited outside the front extremity of the electrode frame.
  • the corrugated radio frequency ablation catheter further comprises a supporting wire provided within a certain lumen of the connecting catheter and the electrode frame, and the front extremity of the wall-attaching adjustment wire is fixed to the supporting wire; or the wall-attaching adjustment wire is a filament obtained through outward branching of the supporting wire.
  • the portion, inside the electrode frame, of the supporting wire is shaped into a corrugation shape, so as to form a corrugation shaping section.
  • the corrugated radio frequency ablation catheter further comprises a shaping wire provided within a certain lumen of the electrode frame, and the front extremity of the wall-attaching adjustment wire is fixed to the shaping wire; or the wall-attaching adjustment wire is a filament obtained through outward branching of the shaping wire.
  • the wall-attaching adjustment wire is composed of two or more filaments
  • the multiple filaments are used for adjusting one corrugation or one section of corrugations on the electrode frame respectively
  • one section of corrugations comprises two or more corrugations
  • the front extremity of each filament is fixed to one end of the corresponding corrugation/corrugation section
  • the other extremity of each filament runs around the corresponding corrugation/corrugation section, runs through lumens in the electrode frame and the connecting catheter, and is then fixed to the corresponding control element provided on the control handle or arranged externally.
  • the multiple sections of corrugations controlled by the multiple filaments respectively overlap.
  • the wall-attaching adjustment wire is eccentrically provided on the electrode frame.
  • the electrodes are arranged at the crests/troughs of the corrugations.
  • a radio frequency ablation apparatus comprises the radio frequency ablation catheter and a radio frequency ablation main unit connected with the radiofrequency ablation catheter.
  • the corrugated radiofrequency ablation catheter having the wall-attaching adjustment wire is novel in structure and can be well adapted to target lumens with different diameters.
  • the electrodes provided on the corrugations can be well attached to the wall.
  • the multiple electrodes located on the corrugations can be distributed into an approximate circle around a target lumen when being attached to the wall.
  • the wall-attaching adjustment wire can be of a multi-filament structure, different corrugation sections of the radiofrequency ablation catheter can be controlled by independently controlling each filament, and the difficulty of diameter adjustment of the corrugated radiofrequency ablation catheter can be simplified.
  • WO2014/166436 discloses a multi-electrode ablation catheter having a helical support frame.
  • US 2002004644 also discloses a helical support structure according to the prior art.
  • the electrode frame can be manufactured integral with the connecting catheter, the connecting frame is the part configured to be corrugated at the front extremity of the connecting catheter, and the electrode frame can also be independently manufactured and then connected with the connecting catheter into a whole.
  • the corrugated electrode frame comprises an outer tube 1 and one or more electrodes 2 provided on the outer tube 1.
  • the outer tube 1 is configured to be a corrugated shape consisting of one or more corrugations; each corrugation can be in the shape of a fold line composed of several straight line segments, such as a triangular wave; each corrugation can also be composed of several curve segments, such as a sine wave or an arc wave; and each corrugation can also be composed of curves and straight lines, such as a trapezoidal wave with a corner.
  • the corrugations can also be in other corrugated shapes.
  • the multiple corrugations can be in the same shape and same size, and can also be in different shapes and different sizes. Detailed explanation will be given with reference to specific embodiments.
  • part of the corrugations are located in different planes, and part of the corrugations are located in the same plane.
  • every two corrugations are located in the same plane, so that the profile projections of the multiple corrugations are in a radial shape as shown in Fig. 1B .
  • the multiple electrodes 2 can be distributed on the corrugations respectively, and preferably, the electrodes 2 are provided at the crests or troughs of the corrugations.
  • the electrodes 2 can be block type electrodes or annular electrodes embedded in the outer periphery of the outer tube 1, the external surfaces of the electrodes 2 can be flush with the external surface of the outer tube 1 or slightly higher than the external surface of the outer tube 1, and the external surfaces of the electrodes 2 can also be lower than the external surface of the outer tube 1.
  • the profile projections of the corrugations in the corrugated electrode frame are distributed in a crossing mode, and the multiple electrodes 2 are arranged at the crest positions respectively.
  • the profile projections, on the electrode frame, of the multiple electrodes 2 can be evenly distributed in the circumferential direction, in other words, the profile projections are distributed on the outer periphery of a target lumen into an approximate circle.
  • the profile projections, on the electrode frame, of the multiple electrodes 2 can be distributed unevenly in the circumferential direction.
  • the multiple corrugations, in the length direction, of the electrode frame can be repeated regularly or randomly, so that the profile projections, on the electrode frame, of the multiple electrodes 2 can overlap.
  • the outer tube 1 of the electrode frame can be a single-lumen tube or a multi-lumen tube, and the outer tube 1 can be made of a polymer material or a metal material, such as stainless steel or memory alloy.
  • the outer tube 1 can be machined from straight tubing and bars, and can also be made into a corrugated special-shaped tube with the segment A. As shown in Fig.
  • the outer tube 1 when the outer tube 1 is a multi-lumen tube, multiple lumens are provided inside the outer tube 1 of the electrode frame besides a central lumen, and a set of radio frequency cables 3 and thermocouple wires 4 is arranged in part of the lumens; the head ends of each set of radio frequency cables 3 and thermocouple wires 4 are arranged in a single electrode 2, wherein the head ends of the radio frequency cables 3 are tightly fixed to the electrode 2 through welding, conductive adhesive gluing or other techniques, the head ends of the two thermocouple wires 4 are welded and coated with thermocouple wire head end insulating layers 5, and then insulated from the radio frequency cables 3 and the electrode 2.
  • a shaping wire 8 is further arranged in one lumen of the outer tube 1, and the shaping wire 8 is fixed in a deformation section of the electrode frame to be used for supporting the corrugated shape of the electrode frame.
  • the electrode frame can also be directly shaped into a corrugated shape, so that the shaping wire 8 can be omitted, for example, when the outer tube is made of memory alloy or a polymer material, the outer tube can be directly shaped, so that the shaping wire 8 can be omitted.
  • a supporting wire 7 is arranged in the central lumen inside the connecting catheter and the electrode frame, the supporting wire 7 can be movably arranged in the central lumen and can also be fixedly arranged in the central lumen, or the supporting wire 7 can be movably or fixedly arranged in other lumens of the connecting catheter and the electrode frame.
  • a camera head 75 can be arranged at the head end of the supporting wire 7 to be used for real-time imaging of the interior of a target lumen.
  • a soft guide wire 9 can also be arranged at the front extremity of the supporting wire 7, the soft guide wire 9 can be a straight-head soft guide wire, and can also be a bent-head soft guide wire as shown in the figure, in this way, the radio frequency ablation catheter can directly enter blood vessels without a guide catheter/sheath, and surgical procedures are simplified.
  • a lumen used for accommodating the wall-attaching adjustment wire 6 is further provided in the outer tube and the connecting catheter, and the rear section of the wall-attaching adjustment wire 6 is slidably provided within one lumen of the connecting catheter and is connected at the rear extremity 60 onto a control element 22 provided on a control handle 20 (see Fig. 5 ).
  • the wall-attaching adjustment wire 6 can slide back and forth in the lumen of the connecting catheter.
  • the lumen for accommodating the wall-attaching adjustment wire 6 can be the central lumen or one of the multiple eccentric lumens distributed on the periphery of the central lumen. As shown in Fig.
  • the front section of the wall-attaching adjustment wire 6 runs through a hole 12 near the rear extremity of the electrode frame and multiple holes provided on different corrugations, and finally the front extremity of the wall-attaching adjustment wire 6 runs through a hole 11 near the front extremity of the electrode frame and returns to the interior of the electrode frame to be fixed.
  • the wall-attaching adjustment wire 6 can slide in the holes provided on different corrugations.
  • the front extremity of the wall-attaching adjustment wire 6 can be fixed at different positions, and the front extremity of the wall-attaching adjustment wire 6 can be fixed to the front extremity of the electrode frame, to the front extremity of the supporting wire 7, or to the shaping wire 8, or the front extremity of the wall-attaching adjustment wire 6 runs through corresponding lumens in the electrode frame 2 and the connecting catheter to be fixed to the control element 22 or a housing of the control handle 20 together with the rear extremity 60 of the wall-attaching adjustment wire 6.
  • the front extremity of the wall-attaching adjustment wire 6 runs through the lumens in the electrode frame and the connecting catheter and returns to the rear extremity of the connecting catheter together with the rear extremity of the wall-attaching adjustment wire 6, and is fixed to the housing of the control handle 20 or the control element 22.
  • the front extremity and the rear extremity of the wall-attaching adjustment wire 6 can be fixed to the same control element 22 as shown in Fig. 5 , or either the front extremity or the rear extremity of the wall-attaching adjustment wire 6 is fixed to the housing of the control handle 20, and the other one is fixed to the control element 22.
  • the wall-attaching adjustment wire 6 is driven to move backwards, and the diameter of the electrode frame can be changed.
  • the front extremity of the wall-attaching adjustment wire 6 can also be simply fixed to the front extremity of the electrode frame, or fixed to the front extremity of the supporting wire 7 or a certain portion, located in the electrode frame, of the supporting wire 7, or fixed to a certain position on the shaping wire 8, or the front extremity of the wall-attaching adjustment wire 6 is fixed in the lumen of the electrode frame, as long as the front extremity of the wall-attaching adjustment wire 6 is fixed, in this way, when the wall-attaching adjustment wire 6 is pulled back, contraction distortion of the electrode frame can be caused under the action of the wall-attaching adjustment wire 6, the diameters of the corrugations of the electrode frame are increased, and the axial distance between the multiple corrugations becomes smaller.
  • the wall-attaching adjustment wire 6 and the supporting wire 7/shaping wire 8 can be made of the same material, and in this case, the wall-attaching adjustment wire 6 can be interpreted as a filament obtained through backward branching of the supporting wire 7/shaping wire 8.
  • the front extremity of the wall-attaching adjustment wire 6 and the front extremity of the shaping wire 8 are fixed together, in this case, the shaping wire 8 and the wall-attaching adjustment wire 6 can be made of the same kind of filament, the wall-attaching adjustment wire 6 and the shaping wire 8 are two filament branches obtained through backward branching of the front extremity of the filament respectively, wherein the branch corresponding to the shaping wire 8 is fixed in a certain lumen of the electrode frame, and the rear section of the branch corresponding to the wall-attaching adjustment wire 6 can slide in the lumen of the electrode frame and/or a body of the catheter.
  • the front extremity/front section of the wall-attaching adjustment wire 6 and the shaping wire 8 can be assembled together through welding, riveting, bonding or other techniques.
  • a control element 23 is further arranged outside the control handle 20, and the tail end 70 of the supporting wire 7 also enters the control handle 20 after protruding to the outside of the connecting catheter, and is fixed to the externally arranged control element 23 after passing through the control handle 20.
  • the control element 22 connected with the wall-attaching adjustment wire 6 can also be provided outside the control handle 20 in an externally arranged way, and the front extremity and/or the rear extremity of the wall-attaching adjustment wire 6 passes through the control handle 20 and then is connected to the externally arranged control element 22.
  • control element 23 can also be arranged on the control handle 20, and the supporting wire 7 penetrates into the control handle 20 and is then directly connected with the control element 23.
  • the control element 23 used for controlling the supporting wire 7 can be omitted.
  • Fig. 6A to Fig. 7B show the use state views of the corrugated radiofrequency ablation catheter entering target lumens with different diameters.
  • the corrugated electrode frame as shown in Fig. 1A has an initial diameter of ⁇ B and a corrugation section length of A.
  • the wall-attaching adjustment wire 6 becomes loose, at the moment, the length of a corrugation section at the front extremity of the catheter can be increased by means of a sheath, so that the corrugation section is approximately straight and can enter a target lumen.
  • Fig. 6A to Fig. 7B show the use state views of the corrugated radiofrequency ablation catheter entering target lumens with different diameters.
  • the corrugated electrode frame when the corrugated electrode frame enters a thin blood vessel through the sheath (suppose that the diameter of the target lumen ⁇ C is smaller than the initial diameter of the corrugations ⁇ B), the corrugations of the electrode frame automatically expand to have a diameter close to the diameter of the target lumen ⁇ C (see Fig. 6B ), the multiple electrodes 2 make contact with the wall of the catheter under the natural expansion of the electrode frame, at the moment, the length of the corrugation section of the electrode frame is increased to be (A-1), and the wall-attaching state of the electrodes 2 can be improved by tensioning the wall-attaching adjustment wire 6. As shown in Fig.
  • the electrodes 2 when the corrugated electrode frame runs through the sheath and enters a thick blood vessel (suppose that the diameter of the target lumen is larger than or equal to the initial diameter of the corrugations ⁇ B), the electrodes 2 can not be well attached to the wall after the electrode frame expands naturally, at the moment, by pulling back the wall-attaching adjustment wire 6, the diameters of the corrugations of the electrode frame can be increased to be equal to or slightly larger than the diameter of the target lumen ⁇ D (see Fig. 7B ), and the multiple electrodes 2 make close contact with the wall of the catheter under the action of the wall-attaching adjustment wire 6.
  • the length of the corrugation section of the electrode frame is shortened to be (A-2), and the axial distance between the multiple electrodes distributed on the electrode frame becomes smaller.
  • the electrode frame is made to enter the sheath by moving the sheath forward or moving the catheter backward, so that the radio frequency ablation catheter can be rotated or moved in the target lumen, or moved out of the target lumen.
  • the corrugated electrode frame is composed of multiple triangular waves, and the multiple corrugations are located in the same plane.
  • the multiple electrodes are located at the crests and troughs of the triangular waves respectively, and due to the fact that the profile projections of the multiple triangular waves overlap, the profile projections of the multiple electrodes overlap too.
  • the catheter can be rotated by a certain angle to conduct ablation on the same position of the target lumen again.
  • the corrugated electrode frame is composed of multiple arc waves, but the multiple corrugations are located in different planes.
  • the multiple electrodes are located at the crests (also called troughs) of the arc waves respectively, so that the profile projections of the multiple electrodes can be distributed in the circumferential direction of the target lumen.
  • the catheter can be directly moved to conduct ablation on other positions of the target lumen, and the operation of rotating the catheter at the same position of the target lumen is omitted.
  • the front section of the wall-attaching adjustment wire 6 after running through the hole near the rear extremity of the electrode frame, the front section of the wall-attaching adjustment wire 6 runs through the holes provided on different corrugations, and finally the front extremity of the wall-attaching adjustment wire 6 runs through the hole near the front extremity of the electrode frame and returns to the interior of the electrode frame to be fixed.
  • the multiple arc waves are located in different planes and the profile projections of the multiple electrodes are distributed in the circumferential direction of the target lumen, compared with the second embodiment, the requirement of radio frequency ablation surgery for the arrangement direction of the electrode frame in the target lumen is low in the third embodiment, and therefore operation is easy.
  • the structure of the second embodiment can enter the target lumen more easily than the structure of the third embodiment.
  • the multiple corrugations of the corrugated electrode frame are all located in different planes, moreover, the multiple corrugations are distributed into an approximate spiral shape, the multiple electrodes are located at the crests (also called troughs) of the corrugations respectively, and therefore the multiple electrodes can be distributed in the circumferential direction of the target lumen.
  • the multiple corrugations can be distributed into one or more circles of spirals, and moreover, the wall-attached adjustment wire 6 can also run through the holes provided on the different corrugations.
  • the corrugated electrode frame is composed of multiple sine waves.
  • the multiple corrugations in the fifth embodiment are located in the same plane, and moreover, the multiple electrodes are located at the crests and troughs of the sine waves respectively.
  • the front section of the wall-attached adjustment wire 6 is fixed at the front extremity after running around the multiple corrugations instead of running through the multiple corrugations.
  • the multiple corrugations in the corrugated electrode frame can be in the shape of a triangular wave (see Fig. 8A ) composed of several straight line segments, an arc wave (see Fig. 10A ) or sine wave (see Fig. 11 ) composed of several arc segments, a trapezoidal wave composed of straight lines and curves, or any other corrugations not shown in the figures.
  • the multiple corrugations can be distributed in the same plane, can also be distributed in different planes, and can even be distributed into an approximate spiral shape in an encircling mode, so that the electrodes can be distributed in the circumferential direction.
  • the corrugated electrode frame can be attached to the wall in any direction in the target lumen during actual ablation surgery.
  • the multiple corrugations forming the corrugated shape are in the same shape.
  • the multiple corrugations forming the corrugated shape can have different shapes and sizes, and the corrugations can be different in form, spacing, crest position, trough position and the like.
  • the wall-attaching states of local electrodes can be adjusted by adjusting the sizes of the corrugations in a local area, and at the same time when the wall-attaching states are adjusted, and meanwhile, the forms of other areas may not be adjusted.
  • Wall-attaching adjustment of the corrugated electrode frame consisting of different corrugations can be achieved by pulling different filament branches in the wall-adjustment adjustment wire 6 composed of multiple filaments. Please see the ninth embodiment for the structure of the wall-adjustment adjustment wire 6 composed of multiple filaments and the wall-attaching adjustment way.
  • the wall-adjustment adjustment wire 6 can be arranged in multiple ways, the front section of the wall-adjustment adjustment wire 6 can run through the holes in the outer tube provided with the multiple corrugations as in the first, second and third embodiments, and can also directly run around the corrugations and then enter the electrode frame to be fixed instead of passing through the outer tube with the multiple corrugations.
  • the front section of the wall-adjustment adjustment wire 6 is entirely exposed from the electrode frame, by allowing the wall-adjustment adjustment wire 6 to run through the holes in different corrugations of the outer tube, the shape change of the electrode frame is controllable, and the wall-attaching effect is better.
  • the structure of the wall-adjustment adjustment wire 6 inside the radio frequency ablation catheter can be similar to the structure in the first embodiment, that is to say, the wall-adjustment adjustment wire 6 is a monofilament independent of the supporting wire 7 and the shaping wire 8; the wall-adjustment adjustment wire 6 also has the function of the supporting wire, or the front extremity of the wall-adjustment adjustment wire 6 can be fixed to the supporting wire 7 to serve as a branch of the supporting wire 7.
  • Both the supporting wire 7 and the wall-adjustment adjustment wire 6 can be made of a filament or a thin tube.
  • the rear section of the wall-adjustment adjustment wire 6 is slidably provided within a certain lumen of the connecting catheter and connected at the rear extremity onto the control handle 20; and after the front section of the wall-attaching adjustment wire 6 runs around the multiple corrugations or runs through the holes provided on the different corrugations, the front extremity of the wall-attaching adjustment wire 6 runs through the hole 11 near the front extremity of the electrode frame, returns to the interior of the electrode frame, protrudes out of the front extremity of the electrode frame and is fixed to the front extremity of the electrode frame or limited outside the front extremity of the electrode frame.
  • a camera head and/or soft guide wire 9 can be provided at the front extremity of the wall-attaching adjustment wire 6.
  • the soft guide wire 9 can be a straight-head soft guide wire as shown in Fig. 12 , and can also be a bent-head soft guide wire as shown in Fig. 13 .
  • the bent-head soft guide wire can be composed of multiple arcs, straight lines or curves, and can have one or more elbows.
  • the wall-attaching adjustment wire 6 when the front extremity of the wall-attaching adjustment wire 6 is fixed to the supporting wire 7, the wall-attaching adjustment wire 6 can be seen as a backward branch 76 of the supporting wire 7.
  • one or two lumens exist inside the connecting catheter and the electrode frame to be used for accommodating two branches of the supporting wire 7.
  • the portion, corresponding to the electrode frame, of the front part of the supporting wire 7 can be configured to be a corrugation shaping section 78 through pre-shaping, the branch, corresponding to the corrugation shaping section 78, of the supporting wire 7 is fixed to the interior of the corresponding lumen, and the rear extremity can be directly fixed in the connecting catheter and can also be fixed in the control handle, so that the electrode frame can remain in a corrugated shape when no external force is applied; the branch 76, corresponding to the wall-attaching adjustment wire, of the supporting wire 7 can be slidably arranged in the lumen, and the tail end can be fixed to the control element provided on the control handle 20 or to the control element arranged externally.
  • the supporting wire 7 and the wall-attaching adjustment wire 6 can be slidably arranged in the same lumen or in two different lumens, the rear extremities of the supporting wire 7 and the wall-attaching adjustment wire 6 are fixed to the corresponding control element provided on the control handle 20 or to the corresponding control element arranged externally after protruding to the outside of the connecting catheter.
  • the wall-attaching adjustment wire 6 When the wall-attaching adjustment wire 6 is combined with the supporting wire 7, or the supporting wire 7 has the function of the shaping wire 8, there can be only one control element 22 connected with the wall-attaching adjustment wire 6 on the control handle 20. Please see Fig. 15A and Fig. 15B for the structure of the control handle 20 in this case. By pushing the control element 22 back to the position as shown in Fig. 15B from the position as shown in Fig. 15A , the wall-attaching adjustment wire 6 can be pulled back, so that the diameter of the electrode frame is increased.
  • Fig. 16 and Fig. 17 are two structure diagrams of the radio frequency ablation catheter in the sixth embodiment.
  • the wall-attaching adjustment wire 6 is arranged near the center of the electrode frame.
  • the sixth embodiment is different from all the five embodiments mentioned above in that the wall-attaching adjustment wire 6 in the present embodiment is eccentrically arranged on the corrugated electrode frame, and the wall-attaching adjustment wire 6 can be located at the highest point of the electrode frame and can also be located at any position between the center and the vertex of the electrode frame.
  • the wall-attaching adjustment wire 6 is eccentrically arranged on the corrugated electrode frame, and the front section of the wall-attaching adjustment wire 6 penetrates out of the hole near the rear extremity of the electrode frame, runs through the holes provided on the corrugations, then runs through the hole near the front extremity of the electrode frame and enters the front extremity of the electrode frame to be fixed.
  • the wall-attaching adjustment wire 6 is eccentrically arranged on the corrugated electrode frame, and the front section of the wall-attaching adjustment wire 6 penetrates out of the hole near the rear extremity of the electrode frame, runs around the multiple corrugations, runs through the hole near the front extremity of the electrode frame and then enters the front extremity of the electrode frame to be fixed.
  • the diameter of the contracted corrugated shape can be greatly increased by pulling the wall-attaching adjustment wire 6, and ideally, the electrode frame can be adapted to blood vessels with diameters larger than the diameter of the corrugation section of the electrode frame. Due to the fact that the range of the diameters of human blood vessels is fixed, the initial diameter of the corrugation shape of the electrode frame in the radio frequency ablation catheter can be reduced substantially, so that the radio frequency ablation catheter can enter blood vessels and move in blood vessels easily.
  • the electrode frame has two corrugations, the wall-attaching adjustment wire 6 is eccentrically arranged, and the wall-attaching adjustment wire 6 can be composed of one filament or two filaments.
  • the wall-attaching adjustment wire 6 is composed of one filament, the rear section of the wall-attaching adjustment wire 6 runs through the lumen in the connecting catheter and returns to the interior of the control handle, and the rear extremity of the wall-attaching adjustment wire 6 is fixed to the control element provided on the control handle or the control element arranged externally; the middle section of the wall-attaching adjustment wire 6 penetrates out of the hole 12 near the rear extremity of the electrode frame, and then two points are fixed to the interior of a hole 13 and a hole 14 provided at the crest at the middle position between two corrugations respectively; then the front extremity of the wall-attaching adjustment wire 6 runs through the hole 11 near the front extremity of the electrode frame, enters the interior of the electrode frame, runs through the lumens in the electrode frame and the connecting catheter, returns to the rear extremity of the connecting catheter, and is fixed to the same control element or to different control elements respectively with the rear extremity.
  • both the front section and the rear section of the wall-attaching adjustment wire 6 run through the lumen inside the connecting catheter, the front extremity and the rear extremity of the wall-attaching adjustment wire 6 are fixed to the corresponding control elements respectively, and both of the two corresponding control elements can be arranged on the control handle 20 or outside the control handle 20, or one control element is arranged on the control handle 20, and the other control element is arranged outside the control handle 20.
  • the front section and the rear section of the wall-attaching adjustment wire 6 are controlled through the two corresponding control elements respectively, and the contraction degrees of two corrugations can be separately adjusted.
  • the front extremity and the rear extremity of the wall-attaching adjustment wire 6 can be fixed to the same control element.
  • the wall-attaching adjustment wire 6 can also be composed of two filaments 6A and 6B used for adjusting two corrugations respectively, the front extremity of each filament is fixed to one end of the corresponding corrugation, and the other extremity of each filament runs around the corresponding corrugation, returns to the interior of the electrode frame from the other end of the corrugation, runs through the lumens in the electrode frame and the connecting catheter, returns to the control handle, and is then fixed to the corresponding control element arranged on the control handle or arranged externally.
  • the front extremity of the filament 6A is fixed in the hole 13 provided between the two corrugations, and the rear extremity of the filament 6A runs through the hole 11 near the front extremity of the electrode frame, returns to the interior of the electrode frame, runs through the lumens in the electrode frame and the connecting catheter, returns to the control handle, and is then fixed to the corresponding control element;
  • the front extremity of the filament 6B is fixed in the other hole 14 provided between the two corrugations, and the rear extremity of the filament 6B runs through the hole 12 near the rear extremity of the electrode frame, returns to the interior of the electrode frame, runs through the lumens in the electrode frame and the connecting catheter, returns to the control handle, and is then fixed to the corresponding control element.
  • the filament 6B is arranged in the same way as Fig. 20 , the front extremity of the filament 6A is fixed in the hole 11 near the front extremity of the electrode frame, and the rear extremity of the filament 6A runs through the hole 13 provided between the two corrugations, returns to the interior of the electrode frame, runs through the lumens in the electrode frame and the connecting catheter, and is then fixed to the corresponding control element.
  • the two corresponding control elements fixed to the filament 6A and the filament 6B respectively can be arranged on the control handle 20 or outside the control handle 20.
  • the wall-attaching adjustment wire parts 6A and 6B are used for controlling the contraction degrees of the two corrugations respectively.
  • the wall-attaching adjustment wire parts 6A and 6B are controlled through the two corresponding control elements respectively, and the contraction degrees of two corrugations can be separately adjusted.
  • the corresponding control elements of the filament 6A and the filament 6B can be the same control element.
  • the wall-attaching adjustment wire 6 is composed of two filaments 6A' and 6B' used for adjusting one corrugation and one section of corrugations (namely a corrugation section) respectively, the front extremity of each filament is fixed to one end of the corresponding corrugation/corrugation section, and the other extremity of each filament runs around the corresponding corrugation/corrugation section, returns to the interior of the electrode frame from the other end of the corrugation/corrugation section, runs through the lumens in the electrode frame and the connecting catheter, returns to the control handle, and is fixed to the corresponding control elements.
  • the front extremity of each filament is fixed to one end of the corresponding corrugation/corrugation section
  • the other extremity of each filament runs around the corresponding corrugation/corrugation section, returns to the interior of the electrode frame from the other end of the corrugation/corrugation section, runs through the lumens in the electrode frame and the connecting catheter, returns to the control handle, and is fixed to the corresponding control elements.
  • the front extremity of the filament 6A' and the front extremity of the filament 6B' are both fixed in the hole 11 near the front extremity of the electrode frame, and the rear extremities 60 of the two filaments run through the hole 13 provided between two corrugations and the hole 12 near the rear extremity of the electrode frame respectively, return to the interior of the electrode frame, and are finally fixed to the corresponding control elements.
  • the filament 6A' is used for controlling the contraction degree of the single corrugation near the front extremity of the electrode frame
  • the filament 6B' is used for controlling the whole corrugation section, in the present embodiment as shown in the figure, the whole corrugation section comprises two corrugations, that is to say, the filament 6B' is used for controlling the contraction degree of two corrugations.
  • the corrugation section adjusted by the filament 6B' comprises the single corrugation adjusted by the filament 6A'.
  • the corresponding control elements connected with the rear extremities of the two filaments respectively can also be one control element.
  • the wall-attaching adjustment wire 6 can be composed of two or more filaments, the multiple filaments are used for adjusting one corrugation or one section of corrugations on the electrode frame respectively, wherein one section of corrugations comprises two or more corrugations, the front extremity of each filament is fixed to one end of the corresponding corrugation/corrugation section, and the other extremity of each filament runs around the corrugation/corrugation section, returns to the interior of the electrode frame from the other end of the corrugation/corrugation section, runs through the lumens in the electrode frame and the connecting catheter and is fixed to the corresponding control elements.
  • the front extremity of the filament is fixed to one end of the corrugation, and the rear extremity of the filament runs through the hole formed in the other end of the corrugation and penetrates into the electrode frame;
  • the front extremity of the filament is fixed to one end of the section of corrugations, and the rear extremity of the filament runs through the hole formed in the other end of the section of corrugations and penetrates into the electrode frame.
  • the multiple sections of corrugations controlled by the multiple filaments respectively can overlap. In the structure shown in Fig. 20 and Fig.
  • the wall-attaching adjustment wire has two filaments, and the two filaments are used for adjusting two corrugations on the electrode frame respectively; while in the structure of the eighth embodiment shown in Fig. 22 and Fig. 23 , the wall-attaching adjustment wire 6 has two filaments, and the two filaments are used for controlling one corrugation and one section of corrugations on the electrode frame respectively.
  • the corresponding corrugation sections of the electrode frame can be expanded in a segmented mode as needed, in other words, only the diameters of the corrugation sections requiring radio frequency are changed, in this way, the diameters of different corrugation sections of the electrode frame can be adjusted more flexibly, and the wall-attaching adjustment difficulty of the radio frequency ablation catheter is reduced.
  • the rear extremities of the multiple filaments can also be fixed to one control element, so that one control element can control all the filaments.
  • the electrode frame of the radio frequency ablation catheter provided in the present embodiment is composed of multiple corrugations in different sizes. Every corrugation can have its own size, or part of the corrugations can have one size and others have a different size. Besides, the multiple corrugations are provided from the front extremity to the rear extremity of the electrode frame in a size increasing mode, or the multiple corrugations are provided from the front extremity to the rear extremity of the electrode frame in a size reducing mode.
  • the wall-attaching adjustment wire 6 composed of multiple filaments is arranged in the radio frequency ablation catheter, the different filaments are used for controlling different parts of the electrode frame respectively, and the corrugation size of a corresponding area of a corrugation section can be changed by pulling different filaments, so that local wall attaching of the electrode frame can be achieved.
  • the sixth embodiment and the seventh embodiment for the specific arrangement mode of the wall-attaching adjustment wire 6 composed of multiple filaments, and the descriptions thereof are omitted herein.
  • the radio frequency ablation catheter using the electrode frame is suitable for the situation that the diameter of a target lumen becomes smaller gradually.
  • the radio frequency ablation catheter can enter a small branch blood vessel with a small diameter from a blood vessel with a large diameter for ablation.
  • the multiple filaments corresponding to small-diameter corrugation sections can be controlled to allow the small-diameter corrugation sections to be well attached to the wall, so that the small branch blood vessel can be ablated by means of the small-diameter corrugation sections; or, large-diameter corrugation sections and the small-diameter corrugation sections can be attached to the wall at the same time by controlling the multiple filaments, so that the large blood vessel and the small blood vessel can be ablated at the same time or in sequence.
  • the radio frequency ablation catheter using the electrode frame is suitable for the situation that the diameter of a target lumen becomes larger gradually.
  • the radio frequency ablation catheter is suitable for sympathetic denervation ablation of the pelvis region via the urethral system, the catheter runs through the urethra, enters the bladder, enters the fallopian tube and reaches the pelvis region, at the moment, the large-diameter corrugation sections can be well attached to the wall of the pelvis region and the small-diameter corrugation sections can be well attached to the wall of the fallopian tube by adjusting the wall-attaching adjustment wire, so that sympathetic nerves near the fallopian tube and the pelvis region can be ablated at the same time.
  • the wall-attaching adjustment wire is arranged in the corrugated radio frequency ablation catheter, and the corrugation diameter of the electrode frame can be changed by pulling back the wall-attaching adjustment wire, so that the wall-attaching state of the electrodes can be improved, and the radio frequency ablation catheter can be adapted to blood vessels in different diameters.
  • the wall-attaching adjustment wire can be of a multi-filament structure, so as to control different corrugation sections of the radio frequency ablation catheter, and reduce the difficulty of diameter adjustment.
  • the radio frequency ablation catheter and a radio frequency ablation apparatus provided by the present invention can be applied to different positions and blood vessels or tracheae with different diameters for neuroablation.
  • the radio frequency ablation catheter and the radiofrequency ablation apparatus can be applied to neuroablation in the renal artery to treat resistant hypertension, neuroablation in the arteria coeliaca to treat diabetes, trachea/bronchus vagus nerve branch ablation to treat asthma, and duodenum vagus nerve branch ablation to treat duodenal ulcers;
  • the radiofrequency ablation catheter and the radiofrequency ablation apparatus can also be used for neuroablation in other blood vessels or tracheae like pelvis and pulmonary artery.
  • the radiofrequency ablation catheter provided by the present invention is not limited to the applications listed above, but can be applied to neuroablation of other portions.
  • the present invention also provides a radiofrequency ablation apparatus comprising the radiofrequency ablation catheter.
  • the radiofrequency ablation apparatus also comprises a radiofrequency ablation main unit connected with the radiofrequency ablation catheter.
  • the wall-attaching adjustment wire inside the electrode frame is correspondingly connected to the control handle after running through the connecting catheter, and the shape of the electrode frame can be changed by pulling the wall-attaching adjustment wire through the control handle, so that the electrode frame can be well attached to the wall in target lumens with different diameters.
  • radiofrequency cables and the thermocouple wires in the electrode frame are connected to corresponding circuits in the radiofrequency ablation main unit respectively through the connecting catheter, so that the radio frequency ablation main unit can conduct radio frequency control and temperature monitoring on the multiple electrodes.
  • the arrangement of the control handle and the radio frequency ablation main unit can be found in previous published patent applications of the applicant, and the descriptions of specific structures thereof are omitted herein.

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EP16792177.4A 2015-05-13 2016-05-10 Corrugated radiofrequency ablation catheter having wall-attaching adjustment wires and apparatus thereof Active EP3295885B1 (en)

Applications Claiming Priority (4)

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CN201510244254 2015-05-13
CN201520605029.2U CN205019161U (zh) 2015-08-12 2015-08-12 具有贴壁调节丝的波纹型射频消融导管及其设备
CN201510492572.0A CN105078571B (zh) 2015-05-13 2015-08-12 具有贴壁调节丝的波纹型射频消融导管及其设备
PCT/CN2016/081621 WO2016180327A1 (zh) 2015-05-13 2016-05-10 具有贴壁调节丝的波纹型射频消融导管及其设备

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NL2022504B1 (en) 2019-02-04 2020-08-19 Elstar Dynamics Patents B V Improved optical modulator
US11099451B1 (en) 2020-07-31 2021-08-24 Elstar Dynamics Patents B.V. Light modulator, substrate comprising electrodes and smart glazing
US11099453B1 (en) 2020-08-03 2021-08-24 Elstar Dynamics Patents B.V. Light modulator, light modulator method and smart glazing
US12007660B2 (en) 2021-06-24 2024-06-11 Elstar Dynamics Patents B.V. Light modulator, substrate comprising electrodes and smart glazing
CN114569232B (zh) * 2022-04-11 2023-05-05 上海安通医疗科技有限公司 一种超声消融导管

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JPH0759863A (ja) * 1993-08-20 1995-03-07 Ep Technol Inc 非対称形状に変化する電極を備えたカテーテル
US6745080B2 (en) * 1999-11-22 2004-06-01 Scimed Life Systems, Inc. Helical and pre-oriented loop structures for supporting diagnostic and therapeutic elements in contact with body tissue
EP2712567A1 (en) * 1999-11-22 2014-04-02 Boston Scientific Limited Loop structures for supporting diagnostic and therapeutic elements in contact with body tissue
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CN104127233B (zh) * 2013-05-03 2019-02-22 上海安通医疗科技有限公司 一种用于调节神经的装置
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CN205019161U (zh) * 2015-08-12 2016-02-10 上海魅丽纬叶医疗科技有限公司 具有贴壁调节丝的波纹型射频消融导管及其设备

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ES2935607T3 (es) 2023-03-08
JP6852898B2 (ja) 2021-03-31
WO2016180327A1 (zh) 2016-11-17
JP2018515226A (ja) 2018-06-14
EP3295885A1 (en) 2018-03-21
US20180116712A1 (en) 2018-05-03

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